Why Is This Study Being Done?

• How well does OraQuick work with Oral Fluid?

• False Positives found in Minnesota • Why did they happen?

Oraquick False Positives

• Minnesota oral OraQuick – 7/2000 (35/10,000) in the first 2 years – 15/266 (600/10,000) next 3 months • New Jersey fingerstick OraQuick – 6/11,000

Positive

Study Subject Recruitment

Fingerstick rapid HIV test Negative Exclude from study Oral Fluid Rapid HIV test Positive Negative CASE Blood Oral + CONTROL if needed Blood Oral Return PRELIMINARY result to client schedule confirmatory result follow-up return result to client

Case study Flowchart

LABEL the 2 OraQuicks SHIP TO CDC FINGERSTICK ORAL TEST + CASE FOR STUDY Collect 2 OraSure Label & ship to CDC DRAW BLOOD 4 Red/Gray top tubes 1 White top tube SPIN IN CENTRIFUGE FREEZE UPSIDE-DOWN

WE'LL PICK-UP AS A BATCH CASE & 3 CONTROLS

CDC TESTING

CASE FS OMT + EIA RNA Confirmatory HIV EIA serum and oral HIV RNA PCR Plasma EIA RNA + EIA + RNA + Wester Blot Serum/Oral Negative Indeterminate return results repeat at 3 weeks F/U if EIA/RNA + return results repeat at 3 weeks F/U Positive EXCLUDE return results counsel refer HIV care EIA + RNA CONTROL FS OMT -

False Positive rate >1.5% (phase 2 of study)

• Additional Testing – Hepatitis A, B and C – Epstein-Barr virus – Cytomegalovirus (CMV) – Herpes simplex virus (HSV) type 1 and 2 – Syphilis – Antinuclear antibodies (ANA) – Rheumatoid factor – Pregnancy – Immunoglobulin testing

Oral OraQuick Study Informed Consent • MUST be obtained • By certified personnel ONLY

Informed Consent

• Legislation requires that patients be informed of all important aspects of a treatment and/or procedures, • Failure to obtain adequate informed consent constitutes medical malpractice.

Components of Informed Consent

• The purposes, procedures, and duration of the research.

• Any procedures which are experimental.

• Any reasonably foreseeable risks, discomforts, and benefits of the research.

• Any potentially beneficial alternative procedures or treatments.

• How confidentiality will be maintained.

CRITICAL POINT!!

• The client may withdraw AT ANY TIME!

• EVEN after they leave!

Study Summary

• • • •

What?

A study of oral OraQuick.

Why?

False Positives reported.

Who?

Fingerstick -, Oral + AND controls

How?

– Test oral and fingerstick, – Complete questionnaire, – Collect additional specimens

Consent Form

• • • • • • • •

Intro Why is this study being done?

Why have you been asked to take part in this study?

Who may take part in this study? And who may not?

What will you be asked to do if you take part in this research study?

How long will the study last and how many subjects will take part in it?

What are the risks and/or discomforts you might experience if you take part in this study?

Are there any benefits for you if you choose to take part in this research study?

• • • • • • •

Consent Form

What are your alternatives if you don’t want to take part in this study?

Who will be allowed to look at your research records from this study?

Will there be any cost to you to take part in this study?

Will you be paid to take part in this study?

What will happen if you do not wish to take part in the study or if you later decide not to stay in the study?

Who can you call if you have any questions?

What are your rights if you decide to take part in this research study?

Conclusion

• Patient's comprehension of the information provided is sometimes limited, rendering the consent not truly "informed.” • Interventions that may prove beneficial: – Providing written materials to accompany oral conversations (copy of consent form –unsigned).

– Asking patients to recap discussions about the procedure.

NOTE

• The counselor is responsible for obtaining the informed consent. • Each Center/Site (but not individual counselor) will receive compensation for the extra work/time involved in the study.

OraQuick Advance

OraQuick Advance

• Very similar to OraQuick 1. Easy to use 2. Quick • Changes 1. Controls 2. Oral Fluid Specimen (OMT)

Quality Control

• • Kit Controls - Now includes

THREE

– HIV-1 Positive Control – black capped – HIV-2 Positive Control – red cap/line – Negative Control – white capped Three results on log sheet!!

  Check EXPIRATION DATES!!

NOTE

: Place black mark on HIV1 vial

Oral Fluid Specimen

• • • • • •

Collection of Oral Fluid

Put on gloves Do not touch flat pad IMPORTANT: Absorbent packet must be included!

Label both device & vial Uncap vial & place in holder Swabbing outer gums above teeth, BOTH top & bottom gums » Demonstrate » Do NOT swab: a) b) Inside of cheek Roof of mouth c) Tongue

Oral Fluid Collection Technique

DO NOT SWAB

• Roof of the mouth • Inside of the cheek; or • The tongue

Técnica de Colección de Fluido Oral

Que hacer : 1. Posicionar La almohadilla lisa encima de los dientes enfronte de la encía exterior.

2. Frotar solo una vez alrededor de la encía superior.

3. Frotar solo una vez alrededor de la encía inferior NO frotar: • El Paladar • El área adentro de la mejilla.

• la lengua

Testing of Oral Fluid

• Insert pad into LABELED vial – Do NOT remove once inserted • Start timer • Read results after 20 minutes but not more than 40 minutes • >40 minutes = INVALID • Record results – indicate Oral on log

• Insert new log sheet

Case study Flowchart

LABEL the 2 OraQuicks SHIP TO CDC FINGERSTICK ORAL TEST + CASE FOR STUDY Collect 2 OraSure Label & ship to CDC DRAW BLOOD 4 serum RED/GRAY top tubes 1 plasma PPT WHITE top tube SPIN IN CENTRIFUGE FREEZE UPSIDE-DOWN

WE'LL PICK-UP AS A BATCH CASE & 3 CONTROLS

Label with CTS number

• 1 Red/Gray top tube • If Oral or Fingerstick Positive, send to Ken Earley (State Lab) for confirmation of preliminary positive

Label with CDC numbers Watch Gender - M/F 1. Red/Gray top tube 1 2. Red/Gray top tube 2 3. Red/Gray top tube 3 4. White top tube 5. Oraquick Oral Device 6. Oraquick Fingerstick Device 7. Orasure 1 8. Orasure 2 9. Consent form

Tube storage

• Store tubes at room temperature – NOT above 100 ° F . • White top tube: Do not use if the stuff on the wall is not white! • Do not use tubes after their expiration dates.

Collection tubes

• The flow properties of the gel barrier are temperature-dependent. Do NOT REFRIGERATE before spinning!

• Blood samples must be centrifuged between 20 minutes and two hours after collection! WAIT AT LEAST 20 MIN!

Centrific Centrifuge

• Six tubes • Rotor accepts 7, 10, and 15mL tubes • No tube cushions are needed

HOW TO OPERATE

• Place tubes in centrifuge – Incomplete seating – come off – the tube can break or the top may NOT GOOD!

• Balance (we’ll talk about it) • Close lid • Set timer dial to 10 minutes • Centrifuge starts automatically, reaches set speed in 15 seconds and stops after set time

Procedure - IMPORTANT

• Balance tubes to minimize the chance of breakage. • Match tubes with similar tubes of the same fill level and place them opposite of one another.

Handling

• Check for possible spills/breakage – If tube breaks, wait 10 minutes before opening centrifuge.

– Use tweezers or clamp to remove damaged tube. NEVER remove broken tubes by hand!

• Remove tubes from centrifuge

Shipping OraQuick/Orasure Devices

• Complete specimen submission form – Put FedEx tracking number on form • Fax form to all three numbers on form • Include form in box • We will pick up your blood samples!

THE END

Why Have You Been Asked to Take Part in This Study?

• Because you have requested a rapid HIV test.

Why Is This Study Being Done?

• We are evaluating a rapid HIV test that uses oral fluid.

• Patients may have a

positive oral fluid test

and a

negative fingerstick test

likely that the negative fingerstick test is the correct result).

(it is more • To find out

why

some people with negative fingerstick tests have positive oral fluid rapid HIV test results and others do not.

• To do this, we need participants who have positive and negative oral fluid tests.

Who May Take Part in This Study? And Who May Not?

Yes • People over 18 who have negative rapid HIV blood tests (fingerstick) may take part in this study No • Diagnosed with HIV • Treated with anti retroviral drugs (AIDS drugs) • Ever got an HIV or AIDS vaccine

How Long Will the Study Last and How Many Subjects Will Take Part in It?

• 1 minute (first part) • up to 30 minutes (second part)

Duration of Study

The study will last in the State of New Jersey until we get: • 50 people who have

negative HIV fingerstick

tests and

positive HIV OMT oral

fluid tests.

• 150 people with

negative fingerstick blood

and

oral

fluid tests.

What Are the Risks And/or Discomforts You Might Experience If You Take Part in This Study?

• If blood is drawn, there may be: – Bruising.

– Bleeding.

– Infection (rare).

• Oral fluid samples: – Salty taste in your mouth.

Continued….

• No follow-up visit = no results of the test (confirmatory).

– If you have a confirmatory HIV test, you may not learn your test result for three weeks.

• Embarrassing questions about possible risks for HIV infection.

–

You do not have to answer

are uncomfortable with.

any questions you • Tests may be done for some serious diseases.

– If these tests are done, you could learn that you have a serious disease.

Extra testing related issues

• If they are done (

they may be not needed

), these tests will be done (

probably

) some months after your blood is drawn.

• If name/way to contact exists - contact to arrange a F/U visit for results. • If anonymous- no way to give the results of any tests, so NOT included in study = can’t get an oral OMT

Tests That Might Be Performed on Blood

• Hepatitis A, B and C • Epstein-Barr virus • Cytomegalovirus (CMV) • Herpes simplex virus (HSV) type 1 and 2 • Syphilis Antinuclear antibodies (ANA) Rheumatoid factor Pregnancy

Confidentiality

• Personal information is confidential • CDC receives de-identified information • Law requires reporting of positive, confirmed results for HIV and/or other diseases tested • Only persons involved in the study will see the information, de-identified

Potential benefits

• Help medicine with the validation of a non-invasive, fast testing method • If you, or someone you know needs a rapid HIV test, it will be done like this; no needles, just a swab

A Study of HIV Testing Using Oral Fluid – Summary Sheet

• •

If you want a rapid HIV test today, it will be done on a drop of blood from a fingerstick

.

We need volunteers

for a study that’s looking at an oral (mouth) version of this test. We’re studying the oral version because some HIV-negative people tested with the oral version got wrong results that said they were HIV-positive. So, we want to compare the blood and oral results in more people.

•

What we want volunteers for:

·You’ll get the rapid fingerstick HIV test result even if you don’t want to do the study.

·We want you to volunteer to do the oral test, too.

•

If the oral test is positive, and for some people with a negative oral test, we’ll want more:

·Answer questions about your HIV risk factors, about other diseases that you might have, and about your teeth and mouth. This might take about 15 minutes.

·We’ll collect blood—about two tablespoons worth. You might get a bruise from getting blood drawn. You could get an infection, but that hardly ever happens.

·We’ll collect more oral samples. This might leave a salty taste in your mouth.

·We might be doing tests for other diseases on this extra blood and oral fluid. If we do, we might call you (even in a few months) if you need to see a doctor about the results.

·We’ll give you a $20 grocery store coupon. Only the people who do the extra stuff get the coupon.

• Everything stays confidential with a code number, just like your HIV blood test. But if we find that you have hepatitis, syphilis or HIV, we have to give information about you to the health department.

Don’t do this if you don’t want to.

• You can get a rapid blood test today anyway.

• If you want to do this: · Ask your HIV counselor any questions you want about this study.

·Don’t do it if you don’t want to.

·Don’t let anyone talk you into it.

·If you say yes now, you can change your mind later and say no.

·Lots more details are in the consent form. You’ll need to sign it.